Last updated on October 2017

Riociguat in Children With Pulmonary Arterial Hypertension (PAH)


Brief description of study

This study is designed to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of riociguat at age-, sex- and body-weight-adjusted doses of 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID in children from ≥6 to less than 18 years with pulmonary arterial hypertension (PAH) group 1. The study consists of two phases: titration phase up to 8 weeks and a maintenance phase up to 16 weeks.

Clinical Study Identifier: NCT02562235

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The Children's Hospital
Aurora, CO United States
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Children's Hospital Boston
Boston, MA United States
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East Carolina University
Greenville, NC United States
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Nationwide Children's Hospital
Columbus, OH United States
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Vanderbilt University Medical School
Nashville, TN United States
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H pital Erasme/Erasmus Ziekenhuis
Bruxelles - Brussel, Belgium
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UZ Leuven Gasthuisberg
Leuven, Belgium
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Fundaci n Valle de Lili
Cali, Colombia
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IPS Centro M dico Imbanaco de Cali S.A.
Cali, Colombia
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Hopital Necker les enfants malades - Paris
Paris, France
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Hopital du Haut Leveque
Pessac, France
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H pital des Enfants
TOULOUSE Cedex 9, France
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Universit tsklinikum Heidelberg
Heidelberg, Germany
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Klinikum der Eberhard-Karls-Universit t T bingen
Tübingen, Germany
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Universit tsklinikum Ulm
Ulm, Germany
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Herz- und Diabeteszentrum Nordrhein-Westfalen (HDZ NRW)
Bad Oeynhausen, Germany
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Deutsches Herzzentrum
Berlin, Germany
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Gottsegen Gyorgy National Cardiology Institute
Budapest, Hungary
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SZTE OK Szent Gy rgyi Albert Klinikai Kozpont
Szeged, Hungary
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IRCCS Ospedale Pediatrico Bambino Ges
Roma, Italy
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A.O. di Padova
Padova, Italy
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Aichi Children's Health and Medical Center
Obu, Japan
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Kitasato University Hospital
Sagamihara, Japan
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Osaka University Hospital
Suita, Japan
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National Cerebral and Cardiovascular Center Hospital
Suita, Japan
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Toho University Omori Medical Center
Ota-ku, Japan
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Keio University Hospital
Shinjuku-ku, Japan
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Instituto Nacional de Cardiolog a "Ignacio Ch vez"
Mexico D.F., Mexico
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Universitair Medisch Centrum Groningen
Groningen, Netherlands
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Instytut "Pomnik - Centrum Zdrowia Dziecka"
Warszawa, Poland
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Wojewodzki Szpital Specjalistyczny
Wroclaw, Poland
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Niculae Stancioiu Heart Institute Cluj-Napoca
Cluj Napoca, Romania
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Emergency Institute of Cardiovascular Diseases & Transplant
Targu Mures, Romania
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Hospital Teresa Herrera
A Coruña, Spain
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Hospital Universitari i Polit cnic La Fe
Valencia, Spain
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Veterans General Hospital
Kaoshiung, Taiwan
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National Cheng Kung University Hospital
Tainan, Taiwan
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Baskent University Medical Faculty
Ankara, Turkey
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Hacettepe Universitesi Tip Fakultesi
Ankara, Turkey
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Behcet Uz Child Training and Research Hospital
Izmir, Turkey
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Great Ormond Street Hospital for Children
London, United Kingdom
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